Combined Effects of Bioactive Compounds in Lipid Profile

NCT01562080 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2013-02-28

No results posted yet for this study

Summary

The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)

Conditions

Interventions

DIETARY_SUPPLEMENT

Armolipid Plus

one tablet per day during 12 weeks

DIETARY_SUPPLEMENT

placebo

one tablet per day during 12 weeks

Sponsors & Collaborators

  • Centro Tecnológico de Nutrición y Salud

    collaborator OTHER
  • Rottapharm Spain

    lead INDUSTRY

Principal Investigators

  • Rosa Solà, MD PhD · Hosp. Universitari Sant Joan de Reus (Tarragona)

  • Jesús Millán, MD PhD · Hosp. Universitario Gregorio Marañón (Madrid)

  • José R Calabuig, MD PhD · Hosp. Universitario La Fe (Valencia)

  • José Villar, MD PhD · Hosp. Universitario Virgen del Rocío (Sevilla)

  • José Puzo, MD PhD · Hosp. Universitario San Jorge (Huesca)

  • Angel Brea, MD · Hosp. Universitario San Pedro ( Logroño)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-06-30
Completion
2012-10-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562080 on ClinicalTrials.gov